About Pricing FAQs Blog

Loading clinical trials...

Your health journey, clearly organized.

Find Clinical Trials →

Legal

Privacy Policy
Terms of Service

© 2026 Clareo Health. All rights reserved.

Back to clinical trial search

UNKNOWNPhase 2/3NCT01247012

Minimization of IntraLipid Versus Omegaven

Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid m...

Lead sponsor: Children's & Women's Health Centre of British Columbia•1 locations•View source on ClinicalTrials.gov

Clareo plain-language summary

What this study is about

Generating AI summary...

Save this trial guide to your notes

Keep your clinical trial research organized — questions to ask, what to expect, and key details.

Sponsors

Lead Sponsor

Children's & Women's Health Centre of British Columbia

Collaborators

Child and Family Research Institute

Infants meeting eligibility will be randomized to receive either 1g/kg/day of Intralipid® 20% or 1g/kg/day Omegaven® 10%. Infants randomized to Intralipid® whose conjugated bilirubin level rises \>100umol/L will be crossed over to receive 1g/kg/day Omegaven®. Monitoring includes liver function tests (AST, ALT,ALP, GGT, Conjugated Bilirubin), Fatty Acid Profile (RBC and serum fatty acids; triene/tetraene ratio), INR (coagulation profile) and cytokine measure (inflammatory markers).

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•infants admitted to neonatal intensive care unit
•severe cholestasis, defined as conjugated bilirubin greater than 35
•receiving at least 60% calories by IV infusion and expected to require intravenous nutrition for at least an additional 28 days
•signed consent

Exclusion Criteria

•hepatitis (TORCH or other viral infection)
•primary liver disease as etiology of cholestasis
•clinically severe bleeding not able to be managed with routine measures
•lethal congenital abnormalities
•congenital heart disease associated with right heart dysfunction

Related studies

A Study to Assess the Genetic Variations in Bile Flow Disorders: Linking Progressive Familial Intrahepatic Cholestasis (PFIC)-Related Genes to Symptoms in Adults With Recurrent Cholestasis in Spain

NCT07191704 · PFIC - Progressive Familial Intrahepatic Cholestasis

Pediatric Evaluation and Registry for Liver Cholestasis in Canada

NCT07411716 · PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS), and more

A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea

NCT07185919 · Progressive Familial Intrahepatic Cholestasis

A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)

NCT07293897 · Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC)

RECRUITINGPhase 4

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

NCT06049680 · Malnutrition, Child, Malnutrition, and more

View all related studies →

Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 7, 2011Terms

Trial snapshot

StatusUNKNOWN

PhasePHASE2/PHASE3

Enrollment40

Start dateDec 2010

Last updatedSep 7, 2011

Condition

Cholestasis Parenteral Nutrition Associated Liver Disease (PNALD)

Locations shown

Children's & Women's Health Centre of BC

Vancouver, British Columbia

For caregivers

Use Clareo to keep notes, questions, trial details, and next steps organized before and after appointments.

Start free trial →

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 7, 2011Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions